GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 400 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Expectorant Cough suppressant - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus - helps make cough more productive - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN DM- GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET
PD-RX PHARMACEUTICALS, INC.
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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH TABLET)
Guaifenesin 400mg
Dextromethorphan HBr 20mg
PURPOSE
Expectorant
Cough suppressant
USES
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus
helps make cough more productive
temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a common cold
WARNINGS
DO NOT USE
if you are now taking a prescription Monoamine Oxidase Inhibitor
(MAOI)(certain
drugs for depression, psychiatric or emotional conditions or
Parkinson's disease) or
for 2 weeks after stopping MAOI drug. If you do not know whether your
prescription
drug contains MAOI, ask your doctor or pharmacist before using this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
persistent or chronic cough, such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)
WHEN USING THIS PRODUCT
do not use more than directed
STOP USE AND ASK A DOCTOR IF
cough lasts more than 7 days, comes back, or occure with fever, rash
or persistent
headache
These could be signs of serious illness.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away (1-
800-222-1222).
DIRECTIONS
take with a full glass of water
this product can be administered without regard for the timing of
meals
do not exceed 6 doses in 24 hours or as directed by doctor
adults and children 12
years of age and over
take 1 tablet every 4
hours as needed
children 6 to under 12
years of age
take ½ tablet every
4 hours as needed
children under 6 years
of age
consult a doctor
OTHER INFORMATION
store at room temperature 15°-30°C (59°-86°F)
INACTIVE INGREDIENTS
magnesium stearate, maltodextrin, microcrystalline celluclose,
povidone, silicon dioxide,
stearic acid.
QUESTIONS?
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